Transcriptomic and Biochemical Changes During a Migraine Attack

Completed

• Conditions: Migraine
• Interventions: Other: Blood samples

• Registration Number: NCT02468622
• Lead Sponsor: Danish Headache Center

Brief Summary

Despite the fact that migraine is a common disorder, the pathogenesis is still not fully elucidated. Studying transcriptomic and biochemical changes during induced and spontaneous migraine-attacks will enhance our understanding and may point to new targets for drug development.

Detailed Description

Migraine is a common neurological disorder affecting approx. 16 % of the European population. Despite the fact that migraine is a common disorder, the pathogenesis is still not sufficiently known.

Studying transcriptomic and biochemical changes during spontaneous migraine-attacks will greatly enhance our understanding of migraine mechanisms and may point to new targets for drug development.

Two blood samples (one for RNA analysis and one for biochemical analysis) are taken on minimum 15 patient with migraine with aura and 15 patients with migraine without aura when they experience a spontaneous migraine attack. A second sample is taken 2 hours after treatment with subcutaneous sumatriptan. Another two blood samples are taken when the patient has been migraine free for at least 5 days and had no other headache for at least 24 hours. A fourth set of blood samples are collected after a cold pressor test.

Study Timeline

• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Study Start: 2015-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Migraine patients who meet IHS criteria for migraine with or without aura of both sexes,
• 18-70 years,
• 45-95 kg.

Exclusion Criteria

• any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week),
• serious somatic or psychiatric disease,
• pregnancy,
• and intake of daily medication (except oral contraceptives).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MO patients	Blood samples	Patients with migraine without aura. We will take blood samples during spontaneous migraine attacks
MA patients	Blood samples	Patients with migraine with aura. We will take blood samples during spontaneous migraine attacks

Primary Outcome Measures

Name	Time	Method
Changes in VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP	2 years	The investigators will use advanced mass spectrometry to measure VIP, glutamate, serotonin, PGE-2, nitric oxide metabolites, cAMP, and cGMP during a migraine attack
Transcriptomic changes	2 year	The investigators will measure transcriptomic changes using Next Generation Sequencing during a migraine attack
Changes in CGRP levels during a migraine attack (CGRP1-37, CGRP1-17, CGRP18-37, CGRP1-26, CGRP27-37)	2 year	The investigators will use advanced mass spectrometry to measure CGRP levels
Changes in PACAP levels during a migraine attack (PACAP-27, PACAP-38 )	2 years	The investigators will use advanced mass spectrometry to measure PACAP levels
Changes in Metabolomics	3 years	The investigators will use advanced mass spectrometry (LC-MS) to measure metabolomics in the 4 blood samples
Changes in Proteomics	3 years	The investigators will use advanced mass spectrometry to measure proteomics in the 4 blood samples

Trial Locations

Locations (1)

Emma Katrine Hansen; 🇩🇰 Copenhagen, Glostrup, Denmark